AMRN needs more clinical trial evidence ( as KM says Real World Evidence ) to raise their Level of Evidence rating ...currently at 11b ( 2 b ) for EU markets such as Germany and France that place a lot of weight on independent trials confirming the risk reduction of the pivotal trial ...R-IT
MITIGATE is the only trial AMRN is funding that can provide this additional CV data . The CV data is exploratory endpoints and listed as such in clinical trials.gov. These endpoint results will be followed ...and if they follow them long enough ( say 2 yrs for event lines to clearly diverge )..hopefully AMRN can use them to increase their Level of Evidence rating .
By the way ..from the Oct CC Reimbursement decisions due from France , Italy and Spain by end of 2022 or early 2023
Ram. part 2 . Theres plenty of downside risk IMHO Risk that MITIGATE fails to show any risk reduction using Vascepa to prevent , shorten , reduce effects etc of Covid . Risk that Kaiser did not continue to dispense Vascepa to these ASCVD patients who should continue to be on Vascepa anyway . Risk that AMRN declined to fund / provide Vascepa beyond the initial 12 mths in the trial and thus lost the opportunity for longer term CV data to support R-IT Kiwi
Ram part 3 And the real risk here with MITIGATE Over 600 patients have been on V in this trial for 2 yrs What if they match these with same patient profile but not on V … and find little difference in CV outcomes after 2 yrs
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